Senior DevOps & Release Engineer

As a Senior DevOps & Release Engineer, you will join a multidisciplinary engineering organization responsible for delivering regulated Software as a Medical Device (SaMD) solutions. You will work closely with Software Engineering, Quality Assurance, Regulatory Affairs, Security, IT, Product, and Research teams to ensure the delivery of secure, reliable, compliant, and audit-ready software platforms used in clinical and field environments. The primary operational environment for this role consists of Linux-based physical devices, workstations, and on-premise systems used for software development, validation, testing, and clinical deployment. You will be responsible for ensuring these systems are reproducible, maintainable, secure, and operationally reliable throughout the software lifecycle. This role serves as the technical authority for Linux operational infrastructure, DevOps, CI/CD, build and release engineering, software deployment, and system automation within a regulated medical device environment. While AWS and Azure are used for selected supporting services and workloads, cloud infrastructure is not the primary focus of the role.

In this role, you will design, implement, and maintain secure and reproducible DevOps infrastructure supporting Linux-based medical software and hardware. You will own the end-to-end software build, packaging, release, deployment, and operational lifecycle while ensuring compliance with FDA, ISO 13485, IEC 62304, and ISO 14971 expectations. You will contribute to operational excellence by implementing scalable automation, secure deployment mechanisms, validated CI/CD systems, and traceable release processes suitable for regulated environments and audit readiness.

DevOps Architecture & Operational Infrastructure • Administer Debian Linux systems • Support Linux-based deployment and security on bare-metal devices (not cloud) • Design, maintain, and evolve DevOps and release engineering platforms • Ensure reliability, reproducibility, and operational consistency across development, validation, testing, and production systems • Align operational practices with risk management and post-market surveillance activities

Build, Packaging & Release Engineering • Own software build, packaging, release, rollback, and patch management processes • Support controlled software release strategies consistent with regulated medical environments